Transvaginal cholecystectomy without laparoscopic support using prototype flexible endoscopic instruments in a porcine model.

BACKGROUND: Transvaginal cholecystectomy with laparoscopic assistance has been performed safely in humans. The next goal was to develop a natural orifice transluminal endoscopic surgery (NOTES) technique to perform cholecystectomy without laparoscopic instruments using one flexible endoscope and flexible accessories. The aim of the study was to test the feasibility of the procedure in a survival porcine model. METHODS: Cholecystectomies were attempted in five 88-130-lb. pigs with a planned 2-week survival. Prototype flexible instruments (NOTES Toolbox, Ethicon Endo-Surgery, Inc.) were used to aid in access, dissection, and removal of the gallbladder via the transvaginal route. RESULTS: Cholecystectomy could be completed without abdominal incision using prototype instruments in four out of five pigs. The cystic duct could be exposed with a flexible hook knife and clips applied. The steerable trocar improved stability and the precision of the dissection. The critical view was established in all five pigs. Dissection of the gallbladder off the liver bed was imprecise resulting in gallbladder perforation in all pigs and liver hemorrhage in two. At necropsy, all clips on the cystic duct were secure and no bile leak, bowel injury, or adhesions were present. CONCLUSIONS: NOTES cholecystectomy without laparoscopic support is feasible but challenging using prototype flexible endoscopic devices. A prototype clip applier was effective in controlling the cystic duct. Further improvements in instrument design to ensure precision and safety are needed before flexible devices should be used for pure NOTES procedures in humans.

In search of the best peritoneal adhesion model: comparison of different techniques in a rat model.

BACKGROUND: Adhesion-related complications after abdominal surgery result in significant morbidity and costs. Results from animal studies investigating prevention or treatment of adhesions are limited due to lack of consistency in existing animal models. The aim of this study was to compare quality and quantity of adhesions in four different models and to find the best model. MATERIALS AND METHODS: This study was approved by the University of Missouri Animal Care and Use Committee (ACUC). Forty female rats were randomly assigned to four different groups of 10 animals each. Adhesion created was performed utilizing the four techniques: Group 1 - parietal peritoneum excision (PPE), Group 2 - parietal peritoneum abrasion (PPA), Group 3 - peritoneal button creation (PBC), and Group 4 - cecal abrasion (CA). Rats were allowed to recover and necropsy was performed on postoperative d 14. Adhesions were scored by an established quantitative and qualitative scoring systems. The midline incision served as the control in each animal. RESULTS: The four groups were not equal with respect to both quantity score (P<0.001) and quality score (P=0.042). The PBC group had the highest quantity of adhesions. The highest quality of adhesion was seen in the PPE group. A multivariate analysis carried out to quantify the performance of each model clearly demonstrated that PBC exhibited the best results in terms of both quantity and quality. CONCLUSIONS: The button technique (PBC) is most consistent and reproducible technique for an intra-abdominal adhesion model. This model can help in the study and development of substances to prevent adhesion formation in the future.

Transvaginal cholecystectomy by using a prototype flexible clip applier.

BACKGROUND: Currently, no endoscopic clips have been proven to be effective in ligating the cystic duct in natural orifice transluminal endoscopic surgery (NOTES) hybrid cholecystectomy. OBJECTIVE: To determine the safety and feasibility of a prototype endoscopic flexible clip applier, which is the only flexible device that deploys a zero-gap clip. DESIGN: Pilot study in a survival porcine model. Necropsy was performed at 2 weeks postprocedure. SETTING: University of Missouri animal laboratory, Columbia, Missouri. INTERVENTION: Transvaginal cholecystectomy was performed on 6 survival pigs using the NOTES Toolbox 1.0. MAIN OUTCOME MEASUREMENTS: Safety and feasibility of the described instrument. Investigators were asked to fill out a standardized, blinded questionnaire on the ease of use and functionality of the flexible clip applier. RESULTS: Clipping of the cystic duct was achieved with the flexible clip applier in all 6 pigs. The mean time for completion of clipping of the cystic duct was 9 minutes. Multiple attempts were required to successfully fire the clip in 2 of 6 pigs. We were unable to visualize the tip of the clip before deployment. Difficulty releasing the clip from the applier once fired and challenges in clip loading were encountered. The clips were visualized in place at necropsy, with no bile leakage, evidence of infection, or injury to surrounding structures seen in any cases. LIMITATIONS: Preclinical animal model. CONCLUSION: The prototype flexible clip applier showed adequate safety and was feasible in clipping the cystic duct in all animals. Design efforts to improve clip visualization, loading, and release are underway.

Global Assessment of Gastrointestinal Endoscopic Skills (GAGES): a valid measurement tool for technical skills in flexible endoscopy.

BACKGROUND: Simulators may improve the efficiency, safety, and quality of endoscopic training. However, no objective, reliable, and valid tool exists to assess clinical endoscopic skills. Such a tool to measure the outcomes of educational strategies is a necessity. This multicenter, multidisciplinary trial aimed to develop instruments for evaluating basic flexible endoscopic skills and to demonstrate their reliability and validity. METHODS: The Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) Upper Endoscopy (GAGES-UE) and Colonoscopy (GAGES-C) are rating scales developed by expert endoscopists. The GAGES scale was completed by the attending endoscopist (A) and an observer (O) in self-assessment (S) during procedures to establish interrater reliability (IRR, using the intraclass correlation coefficient [ICC]) and internal consistency (IC, using Cronbach's alpha). Instrumentation was evaluated when possible and correlated with total scores. Construct and external validity were examined by comparing novice (NOV) and experienced (EXP) endoscopists (Student's t-test). Correlations were calculated for GAGES-UE and GAGES-C with participants who had performed both. RESULTS: For the 139 completed evaluations (60 NOV, 79 EXP), IRR (A vs. O) was 0.96 for GAGES-UE and 0.97 for GAGES-C. The IRR between S and A was 0.78 for GAGES-UE and 0.89 for GAGES-C. The IC was 0.89 for GAGES-UE, and 0.95 for GAGES-C. There were mean differences between the NOV and the EXP endoscopists for GAGE-UE (14.4 +/- 3.7 vs. 18.5 +/- 1.6; p < 0.001) and GAGE-C (11.8 +/- 3.8 vs. 18.8 +/- 1.3; p < 0.001). Good correlation was found between the scores for the GAGE-UE and the GAGE-C (r = 0.75; n = 37). Instrumentation, when performed, demonstrated correlations with total scores of 0.84 (GAGE-UE; n = 73) and 0.86 (GAGE-C; n = 45). CONCLUSIONS: The GAGES-UE and GAGES-C are easy to administer and consistent and meet high standards of reliability and validity. They can be used to measure the effectiveness of simulator training and to provide specific feedback. The GAGES results can be generalized to North American and European endoscopists and may contribute to the definition of technical proficiency in endoscopy.

Transvaginal repair of a large chronic porcine ventral hernia with synthetic mesh using NOTES.

BACKGROUND: Ventral incisional hernias still remain a common surgical problem. We tested the feasibility of transvaginal placement of a large synthetic mesh to repair a porcine hernia. METHODS: Seven pigs were used in this survival model. Each animal had creation of a 5-cm hernia defect and underwent a transvaginal repair of the defect with synthetic mesh. A single colpotomy was made using a 12-cm trocar for an overtube. The mesh was cut to size and placed through the trocar. A single-channel gastroscope with an endoscopic atraumatic grasper was used for grasping sutures. Further fascial sutures were placed every 5 cm. RESULTS: Mesh repair was feasible in all 7 animals. Mean operative time was 133 minutes. Technical difficulties were encountered. No gross contamination was seen at the time of necropsy. However, 5 animals had positive mesh cultures; 7 had positive cultures in the rectouterine space in enrichment broth or on direct culture. CONCLUSION: Transvaginal placement of synthetic mesh to repair a large porcine hernia using NOTES is challenging but feasible. Future studies need to be conducted to develop better techniques and determine the significance of mesh contamination.

Lessons learned establishing an animal model for endoscopic stent placement to treat gastrojejunal anastomotic leaks after gastric bypass.

BACKGROUND: Anastomotic leaks after Roux-en-Y gastric bypass (RYGB) cause significant morbidity and mortality. Placement of enteral stents may be an improvement to the current treatment, which is withholding of oral intake and total parenteral nutrition. METHODS: We established an open RYGB porcine model with a leak at the gastrojejunostomy in three pigs. A pilot study was then performed in five pigs, where Polyflex stents were placed across the leaking anastomosis and fixed with transmural sutures to the Roux limb. After 2 weeks, endoscopy, fluoroscopy, and necropsy were performed. RESULTS: One pig without stent died on the second postoperative day (POD) due to a volvulus unrelated to the leak. In the other two pigs, leaks with large abscesses were found at necropsy. Stents were placed in five pigs but required open surgical manipulation of the delivery system. One pig died on POD 3 due to a perforation in the posterior gastric wall likely caused by the rigid delivery system. One pig died from gastrojejunostomy leakage on POD 5. The leaks were healed in the remaining three pigs after 2 weeks. In one pig, a perforation of the jejunum 4 cm distal to the anastomosis was found. Stent migration to some extent was seen in all pigs. CONCLUSION: Stent placement and fixation were feasible but had a high complication rate for treatment of a leaking gastrojejunal anastomosis in the open porcine model. The stent may have contributed to healing the leak in some pigs. Further studies should focus on improving stent delivery, sealing of the leak, and prevention of stent migration.

Transgastric cholecystectomy using a prototype endoscope with 2 deflecting working channels (with video).

BACKGROUND: Transgastric cholecystectomy has been shown to be feasible in animal models and human case reports but cumbersome with current available instrumentation. OBJECTIVE: To evaluate a prototype endoscope with 2 working channels with deflectors at the distal tip for performance of transgastric cholecystectomy. DESIGN: Animal study, nonsurvival and survival. ANIMALS: Sixteen male pigs. SETTING: University hospital. INTERVENTION: Transgastric cholecystectomy in 6 nonsurvival pigs by using several different dual-channel endoscopes and 10 survival pigs by using the Olympus dual-channel endoscope with an up-down deflecting channel to the left of the objective lens and a left-right deflecting channel located below the lens. Gallbladder fundic retraction was performed with the aid of one laparoscopic grasper. RESULTS: Cholecystectomy was successful in all survival animals. Median procedure time was 81 minutes (range 31-163 minutes), with a decrease over time. Visualization of all structures was achieved, and clipping of the cystic duct and artery was successful in all cases. Dissection of the gallbladder via the left-right channel was enhanced with retraction via the up-down deflecting channel. Nine of 10 animals survived without complications. One animal died, on postoperative day 2, secondary to peritonitis due to a leak from the gastrotomy site. CONCLUSIONS: This endoscope, with deflecting working channels, allows transgastric cholecystectomy in pigs. The endoscope was stable enough to be used without an overtube and facilitated retraction and dissection. This endoscope is promising for use in transgastric cholecystectomy in human beings.

Laparoscopic transperitoneal repair of flank hernias: a retrospective review of 27 patients.

INTRODUCTION: Incisional hernias of the flank are rare with scattered case reports regarding the feasibility of laparoscopic treatment. Treatment can be technically challenging due to patient positioning and adequate mesh overlap and fixation. The aim of this study is to describe the surgical technique and present outcomes of the largest known case series of laparoscopic repair of flank hernia. METHODS: A retrospective chart review was performed from April 2002 to August 2006 at two university hospitals utilizing three surgeons' experience. All patients who underwent a laparoscopic repair of a flank hernia were identified and reviewed with regards to short-term outcomes. RESULTS: Twenty-seven patients were identified with incisional flank hernia treated laparoscopically. Average defect size was 188 cm(2) repaired with an average mesh size of 650 cm(2). Mean operating room (OR) time was 144 min and mean length of stay (LOS) was 3.1 days. There were two reoperations within the cohort: one for a new, unrelated midline hernia 7 months after repair of the initial flank hernia and one for chronic pain with removal of a previously placed polypropylene mesh in the subcutaneous tissue of the abdominal wall. Neither patient had failure of the laparoscopic flank hernia repair. Two other patients were conservatively treated for chronic pain. Mean follow-up was 3.6 months. CONCLUSIONS: In the laparoscopic repair of flank hernias adequate retroperitoneal dissection and wide mesh overlap is imperative. Laparoscopic repair can be performed safely and effectively with good short-term outcomes.

Laparoscopic Nissen fundoplication is a good option in patients with abnormal esophageal motility.

BACKGROUND: Patients with gastroesophageal reflux disease (GERD) and abnormal esophageal motility are the most controversial subgroup of surgically treated patients because of potentially increased risk of postoperative dysphagia. Our study aim was to determine if Nissen fundoplication is associated with increased postoperative dysphagia in patients with ineffective esophageal motility. METHODS: Medical records of all adult (>18 years old) patients who underwent laparoscopic Nissen fundoplication for GERD over 8 years were reviewed retrospectively. Of the 151 patients, 28 (group A) met manometric criteria for abnormal esophageal motility (<30 mmHg mean contractile pressure or <80% peristalsis), whereas 63 (group B) had normal esophageal function. Sixty patients had no manometric data and were therefore excluded from analysis. Follow-up time ranged from 1 month to 5 years. Outcomes (postoperative dysphagia, recurrence of GERD symptoms, free of medications) were compared between groups. RESULTS: Group A had higher age and American Society of Anesthesiologists (ASA) score (p = 0.016 and 0.020), but this did not correlate with outcome. Two patients (7.1%) in group A and three patients (5.3%) in group B had postoperative dysphagia. When adjusted for follow-up time, there was no significant difference between the groups (p = 0.94). Group B had more cases of recurrent heartburn (10.7% versus 3.6%, p = 0.039), and more patients in this group were back on medications (21.4% versus 7.1%, p < 0.05) CONCLUSIONS: This retrospective study found equally low rates of dysphagia following Nissen fundoplication regardless of baseline esophageal motility. Preoperative esophageal dysmotility therefore does not seem to be a contraindication for laparoscopic Nissen fundoplication.

Transgastric placement of biologic mesh to the anterior abdominal wall.

BACKGROUND: Incisional hernia repairs have a risk of wound complications that may be decreased using a natural orifice transluminal endoscopic surgery (NOTES) approach. The aim of this study was to determine the feasibility and safety of transgastric mesh placement to the anterior abdominal wall in a porcine model as a precursor to future studies of NOTES ventral hernia repair. METHODS: The procedure was done under sterile conditions with a double lumen endoscope using a plastic overtube. The endoscope was placed in the stomach preloaded with an overtube. Entrance of the endoscope and overtube into the peritoneal cavity was performed with the percutaneous endoscopic gastrostomy (PEG) technique. A 13 x 15 cm Surgisis Gold mesh with four corner sutures was delivered through the overtube. Transfascial suture passer and endoscopic grasper were used to externalize the sutures and attach the mesh to the anterior abdominal wall. The gastrotomy was closed with a transabdominal gastropexy. The pigs were sacrificed at 2 weeks. RESULTS: Mesh placement was performed in five pigs. Operative time was 215 min (standard deviation, SD 99 min). The most difficult portion of the procedure involved manipulating the gastric overtube, likely exposing the mesh to bacteria in the stomach. Culture-positive abscesses were present at the mesh in 3/5 animals. The mesh appeared intact in 4/5 animals; one of the infected meshes had delamination of 50% of the mesh. Adhesions to the mesh surface varied from 2% to 100%. At 2 weeks, median mesh size was 116 cm2 (range 96-166 cm2) and median contraction was 41% (range 15-51%). Histologic evaluations demonstrated marked inflammation and fibrosis progressing into the mesh material. CONCLUSIONS: Totally endoscopic transgastric delivery and fixation of a biologic mesh to the anterior abdominal wall is feasible. Challenges remain in designing systems for mesh delivery that exclude gastric content. Once these problems can be surmounted NOTES ventral hernia repair may become an option in man.

Colonic sterilization for natural orifice translumenal endoscopic surgery (NOTES) procedures: a comparison of two decontamination protocols.

BACKGROUND: This study aimed to evaluate the effect of two different sterilization protocols on the bacterial counts in the swine colon as preparation for natural orifice translumenal endoscopic surgery (NOTES) surgery. METHODS: In this study, 16 swine were randomized to two different colonic sterilization protocols: low colonic irrigation using 300 ml of a 1:1 dilution of 10% povidone-iodine (Betadine) with sterile saline, followed by 1 g of cefoxitin dissolved in 300 ml of saline or two consecutive 300-ml irrigations using a quaternary ammonium antimicrobial agent (Onamer M). Colonic cultures were taken before colonic cleansing after a decontamination protocol and after completion of the NOTES procedure. The Invitrogen live/dead bacterial viability kit was used to assess for change in the bacterial load. A qualitative culture of peritoneal fluid was obtained at the end of the NOTES procedure. Colon mucosal biopsies obtained immediately after the sterilization procedure and at the 2-week necropsy point were evaluated for mucosal changes. RESULTS: Protocol 1 resulted in an average 93% decrease in live colonic bacteria versus 90% with protocol 2 (nonsignificant difference). After a NOTES procedure, group 1 had a 62% increase in live bacteria and group 2 had a 31% increase (nonsignificant difference). Peritoneal cultures also were obtained. Bacteria were isolated from the peritoneal fluid of all the animals, and two or more species were isolated from 75% of the animals. There was no evidence of peritoneal infection at necropsy. Reactive epithelial changes and mild inflammation were the only pathologic abnormalities. No changes were noted at histologic evaluation of colonic mucosa after 2 weeks, demonstrating that these were temporary changes. CONCLUSION: Colonic irrigation with Betadine and antibiotics are as effective for bacterial decontamination of the swine colon as a quaternary ammonium compound. The results of this study support the use of either protocol. Despite thorough decontamination, peritoneal contamination occurs. The significance of this for humans is unknown.

Endoscopic colotomy closure for natural orifice transluminal endoscopic surgery using a T-fastener prototype in comparison to conventional laparoscopic suture closure.

BACKGROUND: Safe and efficient endoscopic closure of a colotomy is essential for transcolonic peritoneal access or endoscopic full-thickness resection of the colon, if open or laparoscopic surgery is to be avoided. OBJECTIVE: To compare the feasibility and safety of colotomy closure with the newly developed Tissue Approximation System (TAS, Ethicon Endo-Surgery, Inc.) to conventional laparoscopic suture closure. DESIGN: Prospective randomized survival animal study involving 16 pigs. SETTING: University hospital. INTERVENTIONS: Pigs were randomized for closure of a 2- to 3-cm full-thickness colotomy with the TAS or with a conventional laparoscopic running suture. MAIN OUTCOME MEASUREMENTS: Success of colotomy closure, time of colotomy closure, postoperative infection, and complication rates. RESULTS: Colotomies were successfully closed in all animals. Median closure time (range) was 39.5 minutes (25-95 min) in the TAS group and 23 minutes (16-40 min) in the laparoscopic group (P = .0134). There were no postoperative infections or complications. LIMITATIONS: Closure with the TAS was performed under laparoscopic vision. There was no control group without closure of the colotomy site. CONCLUSIONS: Colotomies are safely closed with the TAS with comparable results to laparoscopic closure. The TAS may serve as a useful tool to close full-thickness colon defects or colotomy sites made for transluminal endoscopic procedures.

Gastrotomy creation and closure for NOTES using a gastropexy technique (with video).

BACKGROUND: Safe and efficient gastrotomy creation and closure is pivotal for natural orifice transluminal endoscopic surgery (NOTES). OBJECTIVE: To test a method of transgastric access and closure with commercially available devices. DESIGN: An animal survival study. SETTING: University hospital. PATIENTS: Fifteen pigs. INTERVENTIONS: By using a surgical suture passer, under endoscopic guidance, 3 percutaneous stay sutures were placed, in a triangular fashion, through the gastric wall. A gastrotomy was created with a dilation balloon, which was introduced over a guidewire through the gastric wall in the center of the 3 sutures. After performing a NOTES procedure, the gastrotomy was closed by tying the sutures. Necropsies were performed after 2 to 4 weeks. MAIN OUTCOME MEASUREMENTS: Success and time of gastrotomy creation and closure, and intraoperative and postoperative complications. RESULTS: Gastrotomies were successfully created and closed in all the animals. The median time to create a gastrotomy was 19 minutes (range 11-85 minutes), and the median closure time was 1 minute (range 1-45 minutes). One pig died on postoperative day 1 because of peritonitis caused by a leaking gastrotomy site that extended beyond the stay sutures. There were no other gastrotomy-related complications. All gastrotomies were well healed at the necropsy. LIMITATION: No control group. CONCLUSIONS: We evaluated a simple method by using the principles of the PEG technique combined with a gastropexy, which is familiar to the majority of endoscopists. Strict attention to the gastrotomy site is needed, because one leak was from the gastrotomy site that extended beyond the stay sutures.

Improving rates for screening colonoscopy: Analysis of the health information national trends survey (HINTS I) data.

BACKGROUND: Colonoscopy is an effective modality for colorectal cancer screening. The objectives of this study were to identify colorectal cancer knowledge and barriers to screening colonoscopy in the general US population. METHODS: Data was obtained from the health information national trends survey (HINTS I). The dataset (n = 6369) examined the influence of age, race, gender, education, income, media usage, and interactions with health care providers on knowledge, attitudes, and behavior regarding colonoscopic screening for colorectal cancer. RESULTS: The term 'colonoscopy' was recognized by 80% of participants (over the age of 35), however only 35% of respondents perceived it as a major method for colon cancer screening. Hispanics had the least awareness of colonoscopic screening (16% versus 39% non-Hispanic). Female gender, education, and income all correlated with knowledge and use of colonoscopic screening. There was a positive correlation between media usage and having a colonoscopy (r = 0.095, p < 0.01). Having a health care provider was strongly correlated with having undergone a colonoscopy (r = 0.249, p < 0.01). Reasons for not having a colonoscopy were 'no reason' (29%), 'doctor didn't order it' (24%), and 'didn't know I needed the test' (15%). Personalized materials were the preferred media for receiving cancer-related information. CONCLUSIONS: Knowledge of and participation in screening colonoscopy is low in the US population, especially among Hispanics. The most important immediate action is to increase physician referral for screening colonoscopy. Education materials focused on specific sociodemographic segments and targeted communication campaigns need to be developed to encourage screening.

Prognostic indicators of quality of life after cholecystectomy for biliary dyskinesia.

Approximately 30 per cent of patients who undergo cholecystectomy for biliary dyskinesia will continue to have symptoms after surgery. Quality of life has not been evaluated but may be decreased in these patients. The purpose of this study was to measure quality of life after laparoscopic cholecystectomy in these patients to better define optimal treatment of biliary dyskinesia. All patients with biliary dyskinesia (defined as the absence of gallstones, and a gallbladder ejection fraction of <35%) who underwent cholecystectomy at our institution from January 31, 2000 to January 31, 2005 were identified. Preoperative data including ultrasound, biochemical data, and pathology were retrieved by chart review. Postoperative assessment included the Gastrointestinal Quality of Life Index and a symptom survey. The postoperative quality of life was compared with historic standards. The quality of life was also compared with preoperative variables to determine if any variables predicted outcome. A total of 66 patients were identified as fitting the inclusion criteria. Forty-three patients were reached by phone and 30 agreed to participate. Patients were noted to have good recall as to preoperative symptoms when the retrospective survey of symptoms was compared with the medical record. The mean +/- SD postoperative quality of life in the study population was 113 +/- 20. This is higher than in historic patients with gallbladder disease before (84 +/- 19) and after (102 +/- 13) cholecystectomy. Quality of life in the study group was lower than the healthy control (125 +/- 13). Patients having both postprandial nausea and vomiting before surgery had a lower quality of life (P < 0.029) after surgery as compared with those without these preoperative symptoms. When adjusted for nausea and vomiting, the quality of life in study patients (119 +/- 14) was similar to normal controls. No other symptom, laboratory, pathologic, or sonographic data were predictive of a lower quality of life. Cholecystectomy is beneficial for most patients with biliary dyskinesia. Nausea and vomiting were negative predictors of quality of life after cholecystectomy. These patients with nausea and vomiting may have a global gastrointestinal motility disorder and are less likely to benefit from cholecystectomy.

Management of anastomotic leaks after Roux-en-Y bypass using self-expanding polyester stents.

BACKGROUND: To analyze the outcomes of a series of endoscopically placed polyester self-expanding polyflex stents (SEPSs) for the management of anastomotic leaks after Roux-en-Y bypass. Anastomotic leaks after gastric bypass cause significant morbidity and mortality. Covered polyester SEPSs might have a role in the treatment of these leaks. METHODS: A retrospective chart review was performed from January 2006 to November 2006 that included all acute and chronic leaks treated with SEPSs. RESULTS: A total of 6 patients were treated with stents, with a mean procedure time of 22 minutes. Of these 6 patients, 5 had acute postoperative leaks and 1 had a chronic fistula. Five patients started oral intake 1-6 days after their procedure. All acute leaks had complete healing at a median of 44 days. The patient with a chronic gastrocutaneous fistula required revisional surgery for fistula closure. In addition, 5 patients had stent migration, and 3 required stent replacement. CONCLUSION: An endoscopically placed SEPS provides a less-invasive alternative to treat acute anastomotic leaks after Roux-en-Y bypass while simultaneously allowing oral intake. The results of this case series have demonstrated this treatment to be safe and effective.

Bravo (wireless) ambulatory esophageal pH monitoring: how do day 1 and day 2 results compare?

AIM: To investigate if differences exist for patients' gastroesophageal reflux as measured by the Bravo ambulatory esophageal pH system between d 1 and d 2. METHODS: A retrospective study of 27 consecutive adult patients who underwent Bravo esophageal pH monitoring was performed. Patients underwent EGD under IV conscious sedation prior to Bravo placement. Acid reflux variables and symptom scores for d 1 were compared to d 2. RESULTS: The mean doses of fentanyl and midazolam were 90.4 microg and 7.2 mg, respectively. D 1 results were significantly more elevated than d 2 with respect to total time pH < 4, upright position reflux, and mean number of long refluxes. No statistical difference was noted between the two days for supine position reflux, number of refluxes, duration of longest reflux, episodes of heartburn, and symptom score. CONCLUSION: Patients undergoing Bravo esophageal pH monitoring in association with EGD and moderate conscious sedation experience significantly more acid reflux on d 1 compared to d 2. The IV sedation may be responsible for the increased reflux on d 1. Performed this way, 48-h Bravo results may not be entirely representative of the patients' true GE reflux profile.

The evolving role of staging laparoscopy in the treatment of colorectal hepatic metastasis.

HYPOTHESIS: Laparoscopy is an increasingly important tool in the staging and treatment of hepatic malignancies. This study evaluates the effect of staging laparoscopy (SL) using intraoperative ultrasonography (IOUS) on the regional treatment of isolated hepatic colorectal metastasis. DESIGN: Analytic cohort study. SETTING: Tertiary care center. PATIENTS: Consecutive patients who have a colorectal metastasis confined to the liver and selected for surgical regional treatment. INTERVENTIONS: All patients underwent preoperative evaluation followed by SL/IOUS. Operative plans were based on preoperative imaging and were either carried out or altered intraoperatively according to SL/IOUS findings. MAIN OUTCOME MEASURE: Effect of SL/IOUS on surgical management. RESULTS: Between September 1996 and May 2004 one hundred fifty-two SL/IOUSs were performed in 136 patients (77 males and 59 females), who had a mean (SD) age of 63 (11) years. Data sets were complete in 138 events. All patients had isolated hepatic disease as defined by preoperative computed tomography in 152 (100%) and positron emission tomography in 107 (70%). Staging laparoscopy/IOUS identified surgically untreatable disease in 34 events (25%) because of peritoneal metastases (n = 15), nodal involvement (n = 11), diffuse hepatic disease (n = 5), no identifiable disease (n = 2), and untreatable disease (n = 1). Laparoscopic treatment events included radiofrequency ablations (n = 78), hepatic artery pump implantations (n = 40), resections (n = 26), and combined procedures (n = 37). Overall, SL/IOUS changed the treatment plan in 66 (48%) of 138 of events. This includes 32 (23%) of 138 events in which SL/IOUS findings significantly altered the actual procedure performed relative to the preoperative plan. Three minor complications occurred in the SL/IOUS-only group with a mean (SD) hospital stay of 1.3 (1) days. CONCLUSION: In the regional management of isolated colorectal hepatic metastasis, SL/IOUS avoids unnecessary laparotomies and influences definitive surgical intervention in a substantial proportion of patients.

The association between late-onset fecal incontinence and obstetric anal sphincter defects.

HYPOTHESIS: Endoanal ultrasonographic results have demonstrated that clinically occult anal sphincter damage during vaginal delivery is common. This may or may not be associated with postpartum fecal incontinence (FI). Bayesian meta-analysis of the literature revealed that at least two thirds of obstetric sphincter disruptions are asymptomatic in the postpartum period. Women with postpartum asymptomatic sphincter damage may be at increased risk for FI with aging compared with those without sphincter injury. DESIGN: Case series. SETTING: Tertiary referral center. PATIENTS: After excluding patients with other possible causes of FI, the histories of 124 consecutive women with late-onset FI after vaginal delivery were analyzed. MAIN OUTCOME MEASURES: Endoanal ultrasonographic findings, pudendal nerve terminal motor latency assessment, and anal manometric results. RESULTS: Eighty-eight women (71%) with a median of 3 vaginal deliveries had sphincter defects on endoanal ultrasonographic results. The mean incontinence score, squeeze and resting pressures, median age at last delivery, and median duration of FI were not significantly different between patients with and without sphincter defects. Pudendal neuropathy was more frequent in patients without sphincter defects (10 [30.3%], left side; 12 [36.4%], right side) than in patients with sphincter defects (12 [14.3%] and 16 [19.3%], respectively), with the difference nearly reaching statistical significance (P =.054 and P =.059, respectively). The median age at onset of FI in patients with a sphincter defect was 61.5 years vs 68.0 years in those without a sphincter defect, which was not statistically significant (P =.08). CONCLUSION: Analysis of the current patient population revealed that 88 women (71%) with late-onset FI after vaginal delivery had an anatomical sphincter defect. Thus, FI related to anal sphincter defects is likely to occur even in an elderly population who had experienced vaginal deliveries earlier in life.